Medial Compartment Knee OsteoarthritisNCT07439315
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
A study testing Medial joint distraction brace in people with Medial Compartment Knee Osteoarthritis, run by Icarus Medical Innovations at 1 site in United States.
Trial summary
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Medial Compartment Knee Osteoarthritis
- What is being tested?
- Medial joint distraction brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-70, as significant knee OA is very common for people under 30, and would be more likely correlated to trauma.
- Able to ambulate with or without assistive devices
- Body-mass index (BMI) under 35. This is to minimize the effect of the variable of how the brace fits on the patient. The finding of pain relief will extrapolate to any BMI.
- Willingness and ability to comply with scheduled visits and study procedures
- Willingness and ability to fill out patient questionnaires written in English
- Ability to provide informed consent
- Clinical diagnosis of medial or lateral compartment knee osteoarthritis requiring a KO.
- Subject is suitable for unilateral bracing
Who cannot join
- Significant cognitive impairment interfering with study assessments
- Active infections or wounds at the foot or leg
- Severe spasticity that limits brace fitting or functioning
- History of severe lower limb deformities that would preclude brace use
- History of major joint surgery or joint implants, such as total knee replacement
- Other neurological or musculoskeletal conditions unrelated to the lower limbs that significantly impact gait
Show all 15Show fewer
- Non-ambulatory
- Inability to travel for study procedures or fill out required surveys
- Medical conditions of interest
- Pregnant women
- Prisoners
- Clinical diagnosis of knee osteoarthritis that is not specific to the knee's medial or lateral compartment (multicompartmental, or patellofemoral knee osteoarthritis)
- Self-reported pain score of less than 3 out of 10 in the medial compartment.
- Varus or valgus deformity greater than 12°
- Inability to read/write/communicate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icarus Medical Innovations
Charlottesville, Virginia, 22902
Ben Koerber, 8147909364, koerberbm1@gmail.com
About this study
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
- Conditions
- Medial Compartment Knee Osteoarthritis
- Being tested
- Medial joint distraction brace
- Keywords
- Knee Brace, Osteoarthritis, Joint Distraction
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial joint distraction braceDevice
Patients will receive Icarus Adonis Joint Distraction brace.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis | Experimental | Patients experiencing unicompartment (medial or lateral) osteoarthritis will receive Icarus Adonis Joint Distraction brace. Patients will wear the brace for 12 weeks and document how often they wear the brace and their pain scores. Patients will fill out outcome surveys at 2, 4, 6, 8, and 12 weeks. Receives: Device: Medial joint distraction brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee
Measured: Baseline, 2, 4, 8, 12 weeks
European Quality of Life-5 Dimensions (EQ-5D-5L)
0 to 1, where 1 is perfect health
Measured: Baseline, 2, 4, 8, 12 weeks.
Visual Analogue Scale (VAS)
0-100, zero meaning no pain, 10 meaning severe pain
Measured: Baseline, 2, 4, 8, 12 weeks.
Functional Mobility Assessments
6 minute walk test
Measured: Baseline, 2, 4, 8, 12 weeks
Functional Mobility Assessment
5 times Sit to Stand test
Measured: Baseline, 2, 4, 8, 12 weeks
Functional Mobility Assessment
Timed Up and Go test
Measured: Baseline, 2, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Medial Compartment Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icarus Medical Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439315
- Sponsor's protocol ID
- 303260
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD must be deidentified according to UVA IRB standard. If this would be the case then we would plan to share IPD and publish this study.
Publications
Stetter BJ, Fiedler J, Arndt M, Stein T, Sell S. Impact of a Semi-Rigid Knee Orthotic Intervention on Pain, Physical Activity, and Functional Capacity in Patients with Medial Knee Osteoarthritis. J Clin Med. 2024 Mar 7;13(6):1535. doi: 10.3390/jcm13061535.
PubMed 38541761Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial. J Arthroplasty. 2015 May;30(5):747-53. doi: 10.1016/j.arth.2014.11.036. Epub 2014 Nov 29.
PubMed 25499679Ciolino JD, Kaizer AM, Bonner LB. Guidance on interim analysis methods in clinical trials. J Clin Transl Sci. 2023 May 15;7(1):e124. doi: 10.1017/cts.2023.552. eCollection 2023.
PubMed 37313374Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18.
PubMed 25035839Wilder FV, Barrett JP Jr. The association between medication usage and dropout status among participants of an exercise study for people with osteoarthritis. Phys Ther. 2005 Feb;85(2):142-9.
PubMed 15679465Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PubMed 14613558Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK589304/
PubMed 36810025Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.
PubMed 14727700Balkman GS, Bamer AM, Stevens PM, Weber EL, Morgan SJ, Salem R, Amtmann D, Hafner BJ. Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses. PLoS One. 2023 Nov 2;18(11):e0293848. doi: 10.1371/journal.pone.0293848. eCollection 2023.
PubMed 37917618Jm B, Pw S, Sa L. Lower Extremity Functional Scale (LEFS).
Paluska SA, McKeag DB. Knee braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000 Jan 15;61(2):411-8, 423-4.
PubMed 10670507Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett. 2019 Jan 23;9(2):153-168. doi: 10.1007/s13534-019-00094-z. eCollection 2019 May.
PubMed 31168421DeRogatis M, Anis HK, Sodhi N, Ehiorobo JO, Chughtai M, Bhave A, Mont MA. Non-operative treatment options for knee osteoarthritis. Ann Transl Med. 2019 Oct;7(Suppl 7):S245. doi: 10.21037/atm.2019.06.68.
PubMed 31728369McCormack DJ, Puttock D, Godsiff SP. Medial compartment osteoarthritis of the knee: a review of surgical options. EFORT Open Rev. 2021 Feb 1;6(2):113-117. doi: 10.1302/2058-5241.6.200102. eCollection 2021 Feb.
PubMed 33828854
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07439315
- Acronym / sponsor ID
- 303260
- Conditions
- Medial Compartment Knee Osteoarthritis
- Keywords
- Knee Brace, Osteoarthritis, Joint Distraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Icarus Medical InnovationsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis | Experimental | Device: Medial joint distraction bracePatients experiencing unicompartment (medial or lateral) osteoarthritis will receive Icarus Adonis Joint Distraction brace. Patients will wear the brace for 12 weeks and document how often they wear the brace and their pain scores. Patients will fill out outcome surveys at 2, 4, 6, 8, and 12 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 30-70, as significant knee OA is very common for people under 30, and would be more likely correlated to trauma.
- Able to ambulate with or without assistive devices
- Body-mass index (BMI) under 35. This is to minimize the effect of the variable of how the brace fits on the patient. The finding of pain relief will extrapolate to any BMI.
- Willingness and ability to comply with scheduled visits and study procedures
- Willingness and ability to fill out patient questionnaires written in English
Key exclusion criteria (15 listed)
- Significant cognitive impairment interfering with study assessments
- Active infections or wounds at the foot or leg
- Severe spasticity that limits brace fitting or functioning
- History of severe lower limb deformities that would preclude brace use
- History of major joint surgery or joint implants, such as total knee replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial joint distraction bracePatients will receive Icarus Adonis Joint Distraction brace. | Device | The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 2, 4, 8, 12 weeks
Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: Baseline, 2, 4, 8, 12 weeks.
0 to 1, where 1 is perfect health
Visual Analogue Scale (VAS)
Time frame: Baseline, 2, 4, 8, 12 weeks.
0-100, zero meaning no pain, 10 meaning severe pain
Functional Mobility Assessments
Time frame: Baseline, 2, 4, 8, 12 weeks
6 minute walk test
Functional Mobility Assessment
Time frame: Baseline, 2, 4, 8, 12 weeks
5 times Sit to Stand test
Functional Mobility Assessment
Time frame: Baseline, 2, 4, 8, 12 weeks
Timed Up and Go test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 38541761Stetter BJ, Fiedler J, Arndt M, Stein T, Sell S. Impact of a Semi-Rigid Knee Orthotic Intervention on Pain, Physical Activity, and Functional Capacity in Patients with Medial Knee Osteoarthritis. J Clin Med. 2024 Mar 7;13(6):1535. doi: 10.3390/jcm13061535.
- Background: PubMed 25499679Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial. J Arthroplasty. 2015 May;30(5):747-53. doi: 10.1016/j.arth.2014.11.036. Epub 2014 Nov 29.
- Background: PubMed 37313374Ciolino JD, Kaizer AM, Bonner LB. Guidance on interim analysis methods in clinical trials. J Clin Transl Sci. 2023 May 15;7(1):e124. doi: 10.1017/cts.2023.552. eCollection 2023.
- Background: PubMed 25035839Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18.
- Background: PubMed 15679465Wilder FV, Barrett JP Jr. The association between medication usage and dropout status among participants of an exercise study for people with osteoarthritis. Phys Ther. 2005 Feb;85(2):142-9.
- Background: PubMed 18467932Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
- Background: PubMed 14613558Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- Background: PubMed 36810025Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK589304/
- Background: PubMed 14727700Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.
- Background: PubMed 37917618Balkman GS, Bamer AM, Stevens PM, Weber EL, Morgan SJ, Salem R, Amtmann D, Hafner BJ. Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses. PLoS One. 2023 Nov 2;18(11):e0293848. doi: 10.1371/journal.pone.0293848. eCollection 2023.
- BackgroundJm B, Pw S, Sa L. Lower Extremity Functional Scale (LEFS).
- Background: PubMed 10670507Paluska SA, McKeag DB. Knee braces: current evidence and clinical recommendations for their use. Am Fam Physician. 2000 Jan 15;61(2):411-8, 423-4.
- Individual participant dataSharing planned: Undecided. IPD must be deidentified according to UVA IRB standard. If this would be the case then we would plan to share IPD and publish this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial joint distraction brace in people with Medial Compartment Knee Osteoarthritis, run by Icarus Medical Innovations at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin M Koerber, PhD (8147909364, benk@icarusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 2, 4, 8, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07439315, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.